Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- Reconstruction failure
研究概览
简要总结
For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.
There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.
Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.
Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.
However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.
In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.
The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)
排除标准
- •Delayed prosthetic reconstruction
结局指标
主要结局
Reconstruction failure
时间窗: 2 years
Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)
次要结局
- Reconstruction Complications(2 years)
研究者
Andrea Lisa
Principal Investigator
Humanitas Clinical and Research Center
